Preoperative Oral Carbohydrate Treatment Minimizes Insulin Resistance

Preoperative Oral Carbohydrate Treatment in Diabetes Patients: A Randomized, Double-blind Trial

Insulin resistance is a positive protective reaction against surgery .this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

Study Overview

• Status: Unknown
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: Preoperative Oral Carbohydrate Drink

Detailed Description

Insulin resistance is a positive protective reaction against surgery . As a response to surgery, activation of neuroendocrine and inflammation systems occurs as a protective reaction. However, this resistance has some negative consequences for patient health. It is associated with infectious complications. At the same time, Postoperative insulin resistance has been shown to correlate with the length of postoperative stay in hospital. Recently several clinical studies have shown that a carbohydrate-rich drink given 2 h before surgery diminishes postoperative insulin resistance in patient. The aim of our study is to investigate the influence on insulin resistance in patient with diabetes.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yang z Xiao, MD,PhD; Phone Number: 0866-17709873399; Email: xiaozhaoy@163.com

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • Recruiting
      • The Second Hospital of Dalian Medical University
      • Contact: yang z Xiao, MD,PhD; Phone Number: 0866-17709873399

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients underwent elective open colorectal resection for colorectal carcinoma and electric orthopedic surgery

Exclusion Criteria:

• Weight loss greater than 10 per cent during the previous 6 months
• Renal insufficiency (creatinine, > 3 mg/dl; hemodialysis)
• Hepatic insufficiency (Child-Pugh class, ≥ B)
• Gastro-oesophageal reflux disease
• Gastrointestinal obstruction or conditions (including pharmacological treatment) known to affect gastric emptying rate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oral carbohydrate; fast from midnight the night before surgery, and patients consume 400 ml Preoperative oral carbohydrate preOp®(12.5% carbohydrates, 0.5%kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.	Dietary supplement: Preoperative Oral Carbohydrate Drink; Patients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.
NO_INTERVENTION: Fasting; fast from midnight the night before surgery, and no preoperative oral carbohydrate loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS	Preoperative general well-beings before assessed with the visual analogue scale (VAS).	1 day (preoperative period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA	Preoperative insulin resistance before and immediately after the surgery assessed with the homeostasis model assessment (HOMA)	perioperative period)

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Dalian Medical University
• Investigators: Study Director: yang z Xiao, MD,PhD, 0866-17709873399

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (ACTUAL): September 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Insulin resistance; Diabetes mellitus; Carbohydrate
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: poster2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No